Medical Exercise Device

ABSTRACT

An intra-vaginal device of a new and innovative design that can be used in combination with Kegel exercises or performing ones daily routine to strengthen the muscles of the pelvic floor. The device employs a combination of unique shape, materials as well as carefully engineered deflection, frictional, testing and cleanability characteristics with particular attention to a sexually neutral appearance, comfort during insertion and exercise as well as positive physical feedback to encourage prolonged and frequent use. Benefits of the device include improvement or prevention of urinary leakage and prolapse, increases in sexual intensity, to keep the uterus/bladder/rectum in place as a pessary as well as relief for women suffering from moderate prolapse, and as a dilator to aid women who suffer from vaginismus. With its multiple features and benefits, the device is a vital tool in a woman&#39;s quest for a complete and balanced wellness regimen.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No. 13/909,623, filed Jun. 4, 2013, currently pending, which is a continuation-in-part of U.S. patent application Ser. No. 13/488,333, filed Jun. 4, 2012, abandoned, the contents of each of which are herein incorporated by reference.

BACKGROUND OF THE INVENTION

The present invention related to medical exercise devices, and more specifically, to a well-designed and effective Kegel exercise device to strengthen a woman's pelvic muscles and aid in the prevention and reversal of incontinence. Ergonomically engineered to reinvigorate the pelvic floor, this portable intra-vaginal resistive product is compact, easy to use, and meets the needs of today's women regardless of age and active lifestyle demands. The present invention is comprised of soft, pliable medical grade materials approved for short term implant applications. Its sleek precision engineered body also provides tactile feedback and progressive resistance to strengthen and tone the vaginal sphincter muscles when doing Kegel exercises.

The limitations of Kegel exercise devices in the prior art are that most involve multiple mechanical parts such as tubes, gauges, weights, balls, are cumbersome, and protrude partially outside the body. Add to the discomfort factor the inconvenience of needing to allocate specific times and private spaces to use them.

Currently, 20 million women in the US are affected by urinary incontinence. Notwithstanding underlying medical conditions, incontinence is not inevitable or part of the aging process because evidence exists that incontinence can be prevented and even reversed. In addition, 13 million women affected by urinary incontinence do not use any treatment or product to manage their condition. Furthermore, 1 in 4 women over the age of 50 suffer from prolapse.

As can be seen, there is a need for a one piece, unobtrusive, comfortable, lightweight, easy to insert, remove and clean product that can be worn anywhere and at anytime during the course of a woman's multi-tasking daily routine.

SUMMARY OF THE INVENTION

Embodiments of the present invention provide a soft, light weight, inconspicuous, comfortable, portable, intra-vaginal device with a sleek, sexually neutral, sculptured appearance that strengthens the pelvic floor, pubbococcygeal muscles, of the vagina. The device appears to be of simple design yet fulfills a number of interrelated requirements to facilitate ease of insertion, flexibility, resistance to multidirectional forces during use, providing pleasant feed back to the user and ease of removal. Additional features include ease of cleaning and durability for repeated use. Insertion and removal are facilitated by the device's prolate (football like) outline where the smaller width at the two ends is first to enter and exit the vaginal opening.

The opening in the center of the prolate ring allows the ring to collapse, further reducing resistance to entry and exit. There is also a finger pad to keep one's finger from slipping off of the ring while pushing the ring into place and a tension element that comfortably protrudes from the vaginal opening during use and aids in the removal of the device when use is completed.

With the exception of the small exception of the small variation due to the finger pad, the shape of the end of the prolate ring that enters the vagina first and the end that exits the vagina first are the same. The effectiveness of treatment with the device is enhanced by use of a well-known Kegel exercise routine in addition to leaving the device in place during every day activities and during conventional exercise.

It is one objective of the present invention to provide effective relief from incontinence, and pelvic organ prolapse, provide dilation for vaginismus, promote relaxation of vaginal muscles and to increase sexual intensity.

Another objective of the present invention is to provide calibrated resistance to critical musculature, keeping organs in their youthful positions and functioning in a reliable manner.

Another objective of the present invention is to provide pleasant feedback to the user that motivates frequent and prolonged use.

Another objective of the present invention is to present a neutral appearance that neither upsets the sensibilities of the user during handling, is not obtrusive during use, nor does it present the potential of an embarrassment in the eyes of others.

Another objective of the present invention is to provide comfort during insertion, use and removal.

Another objective of the present invention is to provide ease of cleaning and durability for repeated use.

Another objective of the present invention is to provide effectiveness without the use of weights.

Basically the present invention allows women to accomplish these objectives discreetly with the confidence and freedom from discomfort and pain without anyone knowing and while going about their daily lives.

In one aspect of the present invention, a method for strengthening musculature in an area of a bodily opening comprises inserting a prolate shaped ring into the bodily opening by flattening the prolate shaped ring along its major axis and pressing onto a finger pad disposed on one end of the prolate shaped ring; allowing the prolate shaped ring to at least partially open within the bodily opening; and contracting and releasing muscles to cause flexation of the prolate shaped ring within the bodily opening.

In another aspect of the present invention, a method for strengthening musculature in an area of a bodily opening comprises inserting a prolate shaped ring into the bodily opening by flattening the prolate shaped ring along its major axis and pressing onto a finger pad disposed on one end of the prolate shaped ring, wherein the prolate shaped ring has an unobstructed through opening; allowing the prolate shaped ring to at least partially open within the bodily opening; contracting and releasing muscles to cause flexation of the prolate shaped ring within the bodily opening; and pulling on a tension element attached to the prolate shaped ring to remove the prolate shaped ring from the bodily opening once an exercise is completed, wherein the strengthening musculature provides at least one of relief from incontinence, relieve from pelvic organ prolapse, dilation for vaginismus, promotes relaxation of vaginal muscles, and increases sexual intensity.

These and other features, aspects and advantages of the present invention will become better understood with reference to the following drawings, description and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a perspective view of an exercise device according to an exemplary embodiment of the present invention;

FIG. 1B shows a cross sectional view taken along line A-A of FIG. 1A;

FIGS. 2A through 2C show, respectively front, top and side views of the exercise device of FIG. 1A;

FIGS. 3A through 3C show, respectively, front, top and side views of the prolate shaped spring of the exercise device of FIG. 1A;

FIGS. 4A through 4C show, respectively, front, side and top views of the prolate shaped spring embedded in the exercise device of FIG. 1A;

FIG. 5 is a block diagram showing an exemplary process steps for making the exercise device of FIG. 1A;

FIG. 6 is a block diagram showing exemplary steps for using the exercise device of FIG. 1A;

FIG. 7 is a block diagram showing exemplary steps for a Kegel exercise with the exercise device of FIG. 1A; and

FIGS. 8A through 8D are diagrams showing the application of forces to measure the deflection characteristics of the exercise device of FIG. 1A.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description is of the best currently contemplated modes of carrying out exemplary embodiments of the invention. The description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention, since the scope of the invention is best defined by the appended claims.

Broadly, an embodiment of the present invention provides a one piece, unobtrusive, comfortable, lightweight, easy to insert, remove and clean product. This revolutionary discreet creation can be worn anywhere and at anytime during the course of a woman's multi-tasking daily routine. In addition, with its unique combination of physical and mechanical properties, the present invention is more than a Kegel muscle locator and motivator, it can be used: as an exercise device to help improve/prevent urinary leakage and prolapse, and increase sexual intensity; as a pessary to keep the uterus/bladder/rectum in place for women suffering from moderate prolapse, and as a dilator to aid women who suffer from vaginismus. With its multiple features and benefits, the present invention is a vital tool in a woman's quest for a complete and balanced wellness regimen. As a result, women can now take care of themselves from the inside out on their own terms.

FIG. 1A shows a device 10 according to an exemplary embodiment of the present invention. The device 10 is specifically designed for inter-uterine application by human females. The device 10, with its unusual shape, is being described as a prolate shaped ring 11. The term prolate is generally used to describe a family of solid geometrical shapes that includes the shape of an American football.

The shape, elasticity, hysteresis characteristics, strength, frictional characteristics and weight of the device 10 each play an important part in delivering the two major measures of a successful device. These parameters are measures of the predicted effectiveness at overcoming a number of ailments including, but not limited to, effective relief from incontinence, and pelvic organ prolapse, promoting dilation for vaginismus, promoting relaxation of vaginal muscles and to increase sexual intensity and secondly providing comfort while doing so. The prolate shaped ring 11 is continuous without interruption and is symmetrical about the minor axis “II.”, except for very small exceptions at the base, making the ease of insertion and the ease of extraction approximately equal.

The unobstructed through opening 12 in the center of the prolate shaped ring 11 plays an important role during steps 605, 606 and 608 of the exemplary method of use shown in FIG. 6. The opening 12 allows the prolate shaped ring 11 to collapse during insertion 605 and to spring back into its original shape after insertion 606 is completed. There is provided a finger pad 13 at the intersection of the outer periphery of the prolate shaped ring 11 and the major axis “I.” that is a very slight protrusion from the prolate shaped ring 11 with a flat or concave surface to provide traction with the tip of a user's finger while coaxing the prolate shaped ring 11 into the bodily orifice during insertion. The long dimension of the surface of the finger pad 13 is typically approximately the width of a fingertip and less than half the thickness dimension of the prolate shaped ring 11 while the center of the finger pad lies very close to a line that represents the outline of the outer periphery of the prolate shaped ring 11.

Tension element 14, otherwise referred to as a string, plays an important part in removing the prolate shaped ring 11 from the bodily orifice 608 and transmits the force of extraction from the user's hand to the prolate shaped ring 11 while the prolate shaped ring 11 collapses with the help of the unobstructed opening 12. The tension element 14 is typically only used for extraction as it is too thin and flexible to transmit a compressive force. The tension element 14 is also integral, in one piece, with the prolate shaped ring 11 and typically attaches at two points on either side of the finger pad 13.

FIG. 1B shows a cross section “A-A” from FIG. 1A of the prolate shaped ring 11 that approximates the shape of an isosceles trapezoid 15, the short parallel side “x” of the isosceles trapezoid 15 forms part of an outer periphery of the prolate shaped ring 11. The long parallel side “w” of the isosceles trapezoid 15 forms a part of an inner periphery of the prolate shaped ring 11. The sloped sides “y” and “z” of the isosceles trapezoid 15 are convexly curved. The short parallel side “x” of the isosceles trapezoid 15 is also convexly curved. The cross section of the prolate shaped ring 11 promotes ease of insertion and extraction of the prolate shaped ring 11 as well as comfort while the prolate shaped ring 11 is in use.

FIG. 2 shows an exemplary embodiment of the device 10 of the present invention in three views. Prolate shaped ring 11 has an opening 12, a finger pad 13 and tension element 14. The prolate shaped ring 11 has a major diameter “a” that is taken along the major axis “I.”, a minor diameter “b” that is taken along the minor axis “II.” and a thickness measurement “c” that is taken along the axis “III.” of the opening 12. The prolate shaped ring 11 also has a hoop thickness “d”, a tension element length “e” a tension element thickness of “g” and a tension element spacing of “f”. The second column of Chart 1 shows the dimensions of the prolate shaped ring 11 in millimeters. The third to twelfth columns show the dimensions of the prolate shaped ring 11 in millimeters to possibly adapt the embodiment for users having larger or smaller body sizes.

From Chart 1 it is observed that the minor diameter of the prolate shaped ring “b” is between 63%-77% of the Major Diameter “a” of the prolate shaped ring 11. The thickness of the prolate shaped ring “c” is between 36% and 45% of the Major Diameter “a” of the prolate shaped ring 11. The hoop thickness of the prolate shaped ring “c” is between 36% and 45% of the Major Diameter “a” of the prolate shaped ring 11.

CHART 1 Exemplary 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 1.4 1.5 Embodiment (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) “a” 71.87 50 60 70 80 90 100 110 120 130 150 150 “b” 50.26 30 42 49 56 63 70 77 84 91 98 105 “c” 29.14 20 24 28 32 36 41 45 49 53 57 61 “d” 8.16 6 7 8 9 10 11 12 14 15 16 17 “e” 92.83 65 77 90 103 116 129 142 155 168 181 194 “f” 14.59 10 12 14 16 18 20 22 24 26 28 30 “g” 2.81 2 2 3 3 4 4 4 5 5 5 6

FIG. 3 shows an optional prolate shaped spring 30 that will be shown embedded in the prolate shaped ring 11 in FIG. 4. Prolate shaped spring 30 is a flat spring (has a rectangular cross section). FIG. 3 shows a notch 31 at two points in its periphery located at the tips of its prolate shape. Prolate shaped spring 30 has a major diameter “w”, a minor diameter “x”, a thickness measurement “u” and a hoop thickness “v”. The notch 31 has a notch length “y” and a notch width “z”. The second column of Chart 2 shows the dimensions of the prolate shaped spring 30 in millimeters. The third to twelfth columns show the dimensions of the prolate shaped spring 30 in millimeters to possibly adapt to different body sizes.

From Chart 2 it is observed that the minor diameter of the spring “x” is between 55%-67% of the Major Diameter “a” of the prolate ring 11.

CHART 2 Exemplary 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 1.4 1.5 Embodiment (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) “w” 60.81 42 51 59 68 76 85 93 102 110 118 127 “x” 43.56 30 36 42 48 55 61 67 73 79 85 91 “u” 10.19 7 9 10 11 13 14 16 17 18 20 21 “v” 1.64 1 1 2 2 2 2 3 3 3 3 3 “y” 2.67 2 2 3 3 3 4 4 4 5 5 6 “z” 1.77 1 1 2 2 2 2 3 3 3 3 4

FIG. 4 shows an exemplary embodiment of the device 10 of the present invention with a cut away view of the prolate shaped ring 11 and also having the finger pad 13 and the tension element 13. Spring 30 is shown suspended in the prolate shaped ring 11 so that it is equi-distant from the outer surface of the opening 12 and equidistant from the sides 32 of the prolate shaped ring 11.

FIG. 5 shows the method of making an exemplary embodiment of the present invention. The device 10 and the spring 30 each require a mold for manufacture. Step 500 calls for molding. There are any number of molding methods, processes and machines that can be adapted to manufacture the spring and over-mold to manufacture a finished device. It is considered that it is within the skill of one of ordinary skill to choose or design the mold, process and or machinery. Some of these methods, processes or machinery may also leave molding flash or gates on the prolate shaped spring 30 or over-mold after removal from the mold. Although, the block diagram of FIG. 5 does not include these process steps, it is assumed to be within the skill of one of ordinary skill in the art to choose and or design the requisite ancillary tooling to trim and perform secondary process that are necessitated by the molding processes that are chosen.

Step 501 requires a supply of molding material. The typical embodiment of the present invention uses polycarbonate resin as the molding material and the shape and thickness of the prolate shaped spring 30 are designed to produce resilience of the prolate shaped ring to collapse for insertion into the vaginal opening curing insertion as well as providing the required resistance to motion for strengthening pelvic floor muscles during exercise as described in FIG. 7.

Step 502 is to mold the prolate shaped spring 30 followed by step 503 to remove the prolate shaped spring 30 from the prolate shaped spring mold. Step 504 is to supply the prolate ring and tension element mold which has provisions to suspend the prolate shaped spring 30 to allow molding material to flow completely around the prolate shaped spring 30 to form the finished device of FIG. 1A.

Step 505 is to Insert the prolate shaped spring 30 into the prolate shaped ring and tension element mold followed by step 506 to supply the ring and tension element material. A typical embodiment of the present invention uses a medical grade silicone as the molding material. Step 507 is to mold the prolate shaped ring and tension element, followed by step 508 to extract the prolate shaped ring and tension element from the mold, and step 509 to cool and cure the prolate shaped ring and tension element for 24 hours before step 210 to test the flexural and surface characteristics of the finished device of FIG. 1A. The testing is performed to verify the device meets the resiliency for proper operation as listed in Chart 3.

CHART 3 Direction of force applied to the device Low end of range High end of range Compressive down major axis 0.5 mm/Newton   2 mm/Newton Compressive down minor axis 0.5 mm/Newton   2 mm/Newton Compressive down axis of 0.1 mm/Newton 0.5 mm/Newton opening Bending along major axis 0.02 mm/Newton  0.1 mm/Newton

FIG. 6 shows the method of using an exemplary embodiment of the present invention by females. The major difference in the method for the following uses is the period of time that the device remains in the vagina and whether or not exercising is performed while the device remains in the vagina. These differences are illustrated in Chart 4.

CHART 4 Without Exercise Exercise Periods Possible Medical exercise device X X Non-implant pessary device X X Dilator to relieve vaginismus X X Aid for heightening sexual X X pleasure

The steps of FIG. 6 include Step 600, which is to remove the device from container. The container serves to keep the device clean and physically protected. Cleanliness is mandatory for the good health of the user and the tension element is the most vulnerable part of the device to damage when carried in a pocket or purse. The container that is initially envisioned is a plastic travel box. However, there are any number of containers that would provide the requisite cleanliness and physical protection. The container is considered an accessory that would be within the skill of one of ordinary skill in the art to design or choose.

Step 601 is to supply cleaning solution. The cleaning solution removes any body fluids, odors and sloughed off dead cells from the vaginal area. Soapy water or 70% by volume isopropyl alcohol has been found to be effective. Step 602 is to clean the device and is typically performed by a combination of applying cleaning solution with or without a wipe, optionally rinsing off the cleaning solution from the device and either wiping or allowing the device to air dry.

Step 603 is to supply lubricant to the device. Any water based personal lubricant has been found to be effective as a lubricant to allow insertion of the device through the vaginal opening and into position for optimum use with a minimum of force and discomfort. Step 604, applying lubricant to device at end opposite the finger pad, is achieved by dispensing a drop of the supplied lubricant in the specified location. The cleaning solution, any wipe or rinse material and lubricant are considered a depreciable supply items for device users that would be within the skill of one of ordinary skill in the art to design or choose for use either with or without wipe and rinse materials.

Step 605, inserting the device into the body opening, is achieved by positioning the device with the lubricated end entering first, flat sides of the device oriented vertically, pinching the sides together and pushing the device with one's finger on the finger pad. Step 606 is moving the device into position using the finger pad. This is done until the device is in a comfortable position within the vagina and the tension element protrudes from the vaginal opening.

Step 607, exercising or performing a daily routine, is performed according to Chart 1, depending on the results that the user wants to achieve.

Step 608, removing the device from the body opening by pulling on tension element, is self-explanatory. One should adjust the force and speed of performing this step to minimize discomfort or any damage to sensitive tissues. One may also insert a finger into the through opening of the prolate shaped ring to guide the device from the body.

Step 609, cleaning the device, is performed in the same manner as in step 602, except it is assumed that the device requires more cleaning and possibly repeating the procedure of step 602 multiple times to achieve the requisite cleanliness. Step 610, returning the device to the container, is perhaps the simplest yet most critical step.

FIG. 7 shows the recommended steps for performing the Kegel exercise for use with an exemplary embodiment of the present invention. Step 700 of the exercise involves following steps 600-610 of FIG. 6 to insert the device into the vaginal opening followed by step 701, to position the body in a lying down, sitting or standing position, followed by step 702, to deeply inhale air into the lungs, and step 703, to exhale slowly while squeezing and lifting the pelvic floor without moving the abdomen or buttocks, followed by step 704, to hold the position of step 703 for 10 seconds, and step 705, to fully relax for 5 seconds. The sequence of steps 700 to step 705 is repeated a total of 10 times in step 706. The user then begins the much more rapid sequence of step 707 squeezing and lifting the pelvic floor without moving the abdomen or buttocks for one second, followed by step 708 to fully relax for 1 second and repeating the sequence step 707 and 708 a total of 10 times ending with fully relaxing at step 710. These method steps can help exercise both the fast twitch and the slow twitch muscle fibers. The coordinated breathing in and out are key to the successful outcome of performing these exercises.

FIGS. 8A-8D show the test set up for determining the deflection of the prolate ring 11 with forces applied. FIG. 8A shows a compressive force in the direction of the major axis “I.” of the prolate shaped ring 11. FIG. 8B, shows a compressive force in the direction of the minor axis “II.” of the prolate shaped ring 11. FIG. 8C shows a compressive force in the direction of the opening axis “III.” of the prolate shaped ring 11. FIG. 8D shows a bending force applied so as to bend the major axis “I.” of the prolate shaped ring 11.

It should be understood, of course, that the foregoing relates to exemplary embodiments of the invention and that modifications may be made without departing from the spirit and scope of the invention as set forth in the following claims. 

What is claimed is:
 1. A method for strengthening musculature in an area of a bodily opening comprising: inserting a prolate shaped ring into the bodily opening by flattening the prolate shaped ring along its major axis and pressing onto a finger pad disposed on one end of the prolate shaped ring; allowing the prolate shaped ring to at least partially open within the bodily opening; and contracting and releasing muscles to cause flexation of the prolate shaped ring within the bodily opening.
 2. The method of claim 1, wherein the prolate shaped ring has an unobstructed through opening.
 3. The method of claim 1, wherein the strengthening musculature provides relief from incontinence.
 4. The method of claim 1, wherein the strengthening musculature increases sexual intensity.
 5. The method of claim 1, further comprising pulling on a tension element attached to the prolate shaped ring to remove the prolate shaped ring from the bodily opening.
 6. The method of claim 1, wherein the prolate shaped ring is continuous and symmetrical about the major axis and a minor axis thereof.
 7. The method of claim 1, further comprising embedding a prolate shaped spring in the prolate shaped ring.
 8. The method of claim 7, further comprising notching ends of the prolate shaped spring to form at least one notch, resulting in a reduced pressure requirement to flatten the prolate shaped ring along its major axis as compared to its minor axis.
 9. The method of claim 1, wherein a cross section of the prolate shaped ring, taken perpendicularly to a plane containing the major axis and the minor axis, has an outline of essentially a shape of an isosceles trapezoid.
 10. The method of claim 1, wherein: a short parallel side of the isosceles trapezoid forms a part of an outer circumference of the prolate shaped ring; a long parallel side of the isosceles trapezoid forms a part of an inner circumference of the prolate shaped ring; each of two sloped sides of the isosceles trapezoid are convexly curved; and the short parallel side of the isosceles trapezoid is convexly curved.
 11. The method of claim 8, wherein the notch is disposed at a proximity of an intersection of the prolate shaped ring with the major axis, the notch formed by notching opposite sides, widthwise, of the prolate shaped spring.
 12. A method for strengthening musculature in an area of a bodily opening comprising: inserting a prolate shaped ring into the bodily opening by flattening the prolate shaped ring along its major axis and pressing onto a finger pad disposed on one end of the prolate shaped ring, wherein the prolate shaped ring has an unobstructed through opening; allowing the prolate shaped ring to at least partially open within the bodily opening; contracting and releasing muscles to cause flexation of the prolate shaped ring within the bodily opening; and pulling on a tension element attached to the prolate shaped ring to remove the prolate shaped ring from the bodily opening once an exercise is completed, wherein the method provides at least one of relief from incontinence, relieve from pelvic organ prolapse, dilation for vaginismus, promotes relaxation of vaginal muscles, and increases sexual intensity.
 13. The method of claim 12, wherein the prolate shaped ring is continuous and symmetrical about the major axis and a minor axis thereof.
 14. The method of claim 12, further comprising embedding a prolate shaped spring in the prolate shaped ring.
 15. The method of claim 14, further comprising notching ends of the prolate shaped spring to form at least one notch, resulting in a reduced pressure requirement to flatten the prolate shaped ring along its major axis as compared to its minor axis.
 16. The method of claim 12, wherein a cross section of the prolate shaped ring, taken perpendicularly to a plane containing the major axis and the minor axis, has an outline of essentially a shape of an isosceles trapezoid.
 17. A treatment method comprising: inserting a prolate shaped ring into the bodily opening by flattening the prolate shaped ring along its major axis and pressing onto a finger pad disposed on one end of the prolate shaped ring; allowing the prolate shaped ring to at least partially open within the bodily opening; and contracting and releasing muscles to cause flexation of the prolate shaped ring within the bodily opening.
 18. The treatment method of claim 17, wherein the treatment method aids to prevent pelvic organ prolapse.
 19. The treatment method of claim 17, wherein the treatment method provides dilation for vaginismus.
 20. The treatment method of claim 17, wherein the treatment method promotes relaxation of vaginal muscles. 